(90 days)
Not Found
Not Found
No
The summary describes a powered suction pump with no mention of AI, ML, or related concepts.
Yes
The device is used for medical procedures like pharyngectomy and managing heavy secretions in the mouth and throat, which are therapeutic interventions.
No
The device is described as a suction pump used for procedures and managing secretions, not for identifying a disease or condition.
No
The device description explicitly states it is a "powered suction pump," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a suction device used for removing secretions during surgical procedures in the ENT sector. This is a therapeutic or surgical support device, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is described as a "powered suction pump," which aligns with a surgical or therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, the Mediport 2000 suction device falls under the category of a medical device used for surgical or therapeutic purposes, not an IVD.
N/A
Intended Use / Indications for Use
The Mediport 2000 suction device can be generally used in the ENT sector and is equally suitable for both in-patient and outpatient purposes. It can be used for laryngectomy and outpatient purposes in the event of heavy secretion in one of the organisms or other operations in the mouth and throat area. The mobile may only be used for the applications listed above.
Product codes
BTA
Device Description
Mediport 2000 Mobile (suction device)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth and throat area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-patient and outpatient
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with flowing lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Mr. Martin Herberg Export-Manager Servox Medizintechnik GmbH Servatiusstrasse 69 d, 51109 Köln, Germany
Re: K013585
Trade/Device Name: Mediport 2000 Mobile Regulation Number: 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: October 12, 2001 Received: October 30, 2001
Dear Mr. Herberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. 3 ro(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) w the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1970, as easily the provisions of the Federal Food, DNI, 3 devices that have boon require approval of a premarket approval application (PMA). and Costinctle rice (11ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, morelore, mains of the Act include requirements for annual registration, listing of general ocures, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it rr your device is classince (soo are rols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not nean r rouse of acribed a determination that your device complies with other requirements of the Act that I Dr Has Internations and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Martin Herberg
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
isiam C. Provost
Cot Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510 (k) NUMBER (IF KNOWN) : K013585 -----
MEDIPORT 2000 mobile____ DEVICE NAME:
The Mediport 2000 suction device can be INDICATIONS FOR USE: generally used in the ENT sector and is equally suitable for generally used in the ENT Seconal patients. It can be used for faryngectomy and outpatient purposes. both in-patient and outpactent portion event of heavy secretion The device is designed introse in one of the organisms or other operations in the mouth and throut area. operations in the mobile may only be used for the applications listed above.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)
Muriam C. Parrott
510(k) Number K013585